HeyJaredThe Elendi Files
Welcome to the Elendi Files, your essential guide to navigating the complexities of the global regulatory landscape for medical products.
- Indexed videos, last 90 days
- 11
- Latest publication
- Sep 28, 2026
- Audience
- ~1 subscribers
- Earliest in this view
- Jul 10, 2026
Latest videos
Navigating Thai FDA Market Access and Regulatory Compliance: Strategic Insights into ACTD Submiss... (opens the original)
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Navigating Thai FDA Market Access & Regulatory Compliance: Strategic Insights on ACTD Submissions, MAH Licensing, and Local Representation In the latest episode of The Elendi Files, Teddy Lam (General Manager of ElendiLabs) sits down with Pairoj Grover from RDS Pharmacy to examine how international pharmaceutical, medical device, and healthcare manufacturers can successfully navigate Thailand’s Food and Drug Administration (Thai FDA), leverage the ASEAN Common Technical Dossier (ACTD), and struc
Navigating EU MDR Compliance, Clinical Execution, and Global Market Access: Operationalizing ISO ... (opens the original)
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Navigating EU MDR Compliance, Clinical Execution, and Global Market Access: An Interview with Mark Da Costa of Eclevar MedTech In the latest episode of The Elendi Files, Teddy Lam, General Manager of ElendiLabs, sits down with Mark Da Costa, Chief Operating Officer and Chief Medical Officer for Cardiovascular Technologies at Eclevar MedTech, to unpack how manufacturers actually operationalize EU MDR 2017/745 — from PMCF real-world evidence and Notified Body deficiency responses through ISO 14155
Navigating MedTech Regulatory Compliance in Australia, Canada, and MDSAP: Strategic Insights into... (opens the original)
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Navigating MedTech Market Access in Australia, Canada & Beyond: Strategic Insights on TGA, Health Canada, and MDSAP Compliance In the latest episode of The Elendi Files, Teddy Lam (General Manager of ElendiLabs) sits down with freelance global regulatory consultant Daniel Di Marino to examine Australian Therapeutic Goods Administration (TGA) regulations, Health Canada medical device licensing, the Medical Device Single Audit Program (MDSAP), and practical global expansion strategies for MedTech
Navigating Pharmaceutical and MedTech Regulatory Compliance in Kenya and East Africa: Strategic I... (opens the original)
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Navigating Pharmaceutical & MedTech Regulatory Access in Kenya and East Africa: Strategic Insights on PPB Registrations, Reliance Pathways, and Scientific Office Representation In the latest episode of The Elendi Files, Teddy Lam (General Manager of ElendiLabs) sits down with Dr. Munyao Florence Wambui, Founder and Compliance Consultant at Pharma Partner (a PPB-recognised Scientific Office in Nairobi, Kenya). Together, they examine how foreign pharmaceutical, medical device, cosmetic, and food s
MedTech Market Access in the EU and Beyond: Strategic Insights on MDR, IVDR, and Global Submissions (opens the original)
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MedTech Market Access in the EU & Emerging Markets: Strategic Insights on MDR, SaMD, SFDA, and Global SubmissionsBuilding a robust EU Technical File under MDR/IVDR is more than a regional compliance requirement—it serves as a foundational "passport" for global market expansion. In the latest episode of The Elendi Files, Teddy Lam (General Manager of ElendiLabs) sits down with global regulatory affairs specialist Darshna to explore the nuances of EU MDR/IVDR compliance, Software as a Medical Devi
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~1 subscribers
Measured Sep 19, 2026
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